Algin is a material obtained from seaweed. It can be converted into alginic acid which is insoluble and soluble salts such as sodium alginate or insoluble salts such as calcium alginate can be obtained therefrom. Alginates are also readily available from pharmaceutical sources, most commonly as the salt form, e.g. sodium alginate.
The use of calcium and sodium alginate materials made into wool, gauze and the like in surgery and in the dressing of wounds has been well known for many years, having, for example, been reported in surgery annals as early as 1947. More recently, various alginate wound dressing products have become commercially available, mainly in the form of calcium alginate fibers.
For example, in the United Kingdom, where much of the technology had its origin, dressings were made by converting sodium alginate into calcium alginate and then processing the fiber into a nonwoven fabric, to be cut into size, packaged and sterilized.
UK-based research in the 60's and 70's showed that alginates such as those produced in the above manner, e.g. SORBSON, marketed by Steriseal, produced the ideal warm, moist environment for healing wounds, including long-standing infected ulcers. This was found to be due to the ability of the fiber to react with the wound exudate and form a gel which is absorbent but keeps the wound moist and which can be changed by washing the saturated dressing away with saline solution. As a result, newly formed tissue is said not to be disturbed.
KALTOSTAT, developed by BritCair, another British Company, is a calcium alginate fiber produced by a special wet-spinning process from a variety of seaweed selected for having the best type of molecular construction for alginate fiber. Supplied in the form of nonwoven wound dressings for the treatment of exudating wounds, the product is said to encourage the formation of controlled ion-active gel over the wound site which reacts with the sodium ions in exudate or blood to aid wound healing.
A dual-treatment product is also offered under the name KATOCARB in which the wound-contact layer is of a calcium alginate fiber to which is bonded a woven pad of activated charcoal, the outer layer being a nonwoven polyester/viscose. The product is intended for use on wounds that are complicated by a bacterial infection and offensive odors.
Windsor Laboratories, yet another UK company, has introduced a woven calcium alginate dressing for over the counter pharmacy sale only. Called STOP HEMO, the sodium alginate formed with the exchange of sodium ions in the blood for the calcium ions forms a gel which acts as a dressing, while the calcium ions are said to encourage clot formation.
While alginate fiber dressings such as the commercially available ones mentioned above are highly efficacious in wound management, they nevertheless suffer the disadvantage of requiring the clinician to physically remove the resulting gel with the body fluids physically by wiping or by flushing with saline.
Other forms of alginate dressings are also known in the art, as evidenced by the patent literature. While not intended to represent a full survey of the patent literature, the following patents may nevertheless be taken as being fairly illustrative of the state of the art.
U.S. Pat. No. 2,512,616 observes that alginates exist in several forms, but that fibrous forms are preferred for use in surgical dressings. Alginates woven into a gauze or in the form of loose wool similar to absorbent cotton are particularly identified as being useful.
U.S. Pat. No. 3,879,168 discloses a partially soluble alginic material in the form of a gauze or wool, suitable for the preparation of surgical dressings, based on an alginic acid and containing calcium, sodium and acid forms, e.g. in the ratio of 4:5:1 and characterized by a calcium content of 2 to 6 percent and a reaction pH of 4 to 7.
U.S. Pat. No. 4,837,024 teaches the healing of a surface wound can be promoted by contacting the wound surfaces with a suspension of particles of collagen and a glycosaminoglycan that is chemotactic of fiberblasts and/or endothelial cells. Typical glycosaminoglycans are said to include alginates most commonly available as the sodium salt.
U.S. Pat. No. 4,948,575 is directed to dimensionally stable alginate hydrogel foam wound dressings formed in place in the wound cavity or on the wound surface from a reactive composition that foams as it gels. As is disclosed, the hydrogel foam is formed by mixing together a first liquid component (Component A) comprising an aqueous suspension of particles of water-insoluble di- or trivalent metal salt and an effervescent compound which effervesces when reacted with an acid; and a second liquid component (Component B) comprising an aqueous solution of a biocompatible water-soluble acid, wherein at least one of the Components A and B further comprises water-soluble alginate dissolved therein.
In the BACKGROUND OF THE ART, the patentees discuss the alginate fiber dressings such as those commercially available ones mentioned above, noting that although the fibrous wound dressings perform well, they have many inherent disadvantages such as difficulty in handling, poor structural integrity and tendency to shed fibers when dry, skill required to apply the dressings to the wound, the handling problems being aggravated when one's fingers are not completely dry, etc. Additionally, the patentees note that because the alginate fibers are highly absorbent, dressings based upon high basis weight webs of the fibers are more likely to desiccate a wound if applied to the wound in a dry condition. The manufacturer of the [above-mentioned] KALOSTAT dressing avoids this problem by recommending that the dressing be moistened before application to the wound. Nonfibrous alginate wound dressings are also said to be known, as illustrated by U.S. Pat. No. 4,393,048 of Mason et al disclosing a wound dressing comprising a water-soluble hydrogel of alkali metal alginate and glycerine. Additionally, Swedish Patent Application Publication Number 424,956 published Aug. 23, 1982 was cited as disclosing a water-insoluble alginate hydrogel wound dressing.
British Patent Specification No. 629,419 discloses a haemostatic surgical dressing which is formed by impregnating a cotton gauze or other fibrous material with relatively large quantities of insoluble alginate.
British Patent Specification 1,329,693 also discloses a surgical dressing comprising an alginate as a haemostat, the alginate being combined with a specified water-soluble polymer, apparently to allow the alginate to be cast or spread in the form of a film, sheet or block. The advantage is said to be that the film, sheet, or block slowly dissolves in contact with a wound or burn to release the alginate which is then free to exhibit haemostatic properties.
British Patent Specification No. 1,394,742 teaches a surgical dressing material comprising a layer of knitted alginic gauze adhered to a layer of fibrous backing material, the alginic material being calcium alginate or calcium alginate in which part of the calcium content has been replaced by sodium to render the material more soluble in water (so-called "converted calcium alginate"). The preferred converted calcium alginate is said to have a calcium content of 3 to 5% by weight and a Ph not less than 4.
European Patent Application Number 87303252.8 (Publication Number 0 243 069) discloses a wound-contacting layer fixed to a substantially liquid-impermeable plastics backing layer, the wound-contacting layer being formed from an alginate, the backing layer extending beyond the edges of the wound-contacting layer to provide a marginal portion which is coated with adhesive. The alginate may, for example, be calcium alginate, silver alginate, zinc alginate, sodium alginate, or mixtures thereof, calcium alginate being particularly preferred. As disclosed, the alginate layer may conveniently be in the form of a pad of alginate fibers. The pad may be lightly bonded together to give a degree of integrity and resistance to delamination.
Of the various prior publications known to Applicant, perhaps the most relevant to the instant invention is UK Patent Application No. 8917154.0 (Publication No. 2,221,620 A) of Johnson & Johnson.
According to the invention described and claimed therein, there is provided a wound dressing material comprising a fibrous substrate having a discontinuous coating of a pharmaceutically acceptable alginate deposited on a surface thereof. By applying the alginate coating directly to the surface of a fibrous substrate, it is stated that a very large surface area of alginate in relation to its weight can be achieved. Effective homeostasis can therefore be obtained with relatively small amounts of alginate.
The alginate coating may comprise any pharmaceutically acceptable cationic alginate, such as sodium, calcium, potassium and ammonium alginates or mixtures thereof, sodium and calcium alginates and their mixtures being said to be preferred.
As is further stated in the aforementioned UK Application of Johnson & Johnson:
"Since it is not desired to form a continuous film of alginate on the substrate, there is no need to include film-forming water-soluble polymers in the alginate coating. Indeed, it is preferred that the alginate coating contain less than 40% by weight of other polymers, and more preferably less than 15% by weight. It is particularly preferred that no more than 5% by weight of other polymers be included in the alginate coatings, because their presence may interfere with the haemostatic effect of the alginate."
"In the absence of substantial quantities of a film-forming polymer, alginates tend to be rather friable, and the alginate coating in the wound dressing material for the present invention therefore preferably also contains a plasticizer such as ethylene glycol, propylene glycol or hexylene glycol, or an alkyl citrate or an appropriate mixture. The preferred plasticizer is glycerol (propan-1,2,3-triol). The plasticizer may constitute from 0% to 80% by weight of the coating, and preferably from 10 to 70% by weight. It is particularly preferred that the plasticizer be present in the coating in amount between 30 and 60% by weight."
"The alginate coating may optionally incorporate other additives such as antiseptics, analgesics or other medicaments, preferably in amounts less than 5% by weight, more preferably less than 2% by weight, and most preferably less than 1% by weight."
"When an alginate coating is applied to a fibrous substrate in accordance with the invention, the individual fibers which lie close to the surface of the substrate are at least partly coated. Also, extremely thin films of alginate may be formed between adjacent fibers near points of crossover. A discrete film or layer of alginate on the surface of the substrate is avoided, so that the permeability of the substrate to gases (such as air and water vapour) is not lost . . . "
"The alginate is preferably applied to the substrate as a viscous aqueous, or substantially aqueous, fluid. The viscosity of the aqueous suspension of the alginate composition may be adjusted to suit the coating technique employed . . . "
"The wound dressing materials of the present invention are suitable for use in a variety of forms. For example, they may be used either alone (being secured in place by bandaging, adhesive tape, or any other suitable means), or they may be formed into composite dressings. Indeed, the material of the present invention can advantageously be used in any of the circumstances in which absorbent wound dressing pads are conventionally used. They are particularly suitable for use as post-operative dressings."
"Composite dressings including the dressing material of the present invention will generally comprise a fibrous pad having an alginate coating on one surface, and a backing material secured to the opposed surface. The backing material may be porous or non-porous, but materials which are impermeable to water but permeable to water vapour are particularly preferred. Such materials include, for example, cast polyurethane films. Alternatively, the backing material may be a perforated plastics film, such as those conventionally used in first-aid dressings."
Neither Applicant nor its corporate assignee, the Kendall Company which has a substantial business in wound care, has any knowledge of commercial exploitation of the above-described Johnson & Johnson alginate dressing.
In any case, it will be seen that the published UK application, substantial portions of which has been described above, teaches that the composition for coating the dressing should contain, in addition to the cationic alginate, a plasticizer as well as a viscosity adjuster to facilitate coating. Additionally, as disclosed on page 5 of the application, if a sodium/calcium alginate coating is required, a viscous aqueous solution of sodium alginate can be prevented from forming an immediate gel in the presence of calcium ions by the inclusion of pH controlling materials such as glucono lactone or adipic acid/sequestering agent.
Apart from the added manufacturing cost of including such reagents which have no beneficial effect on wound care, it will be appreciated that federal drug regulations may require biocompatability data showing that these additives cause no adverse effects, whether topically or systemically by transdermal diffusion, thereby complicating approval for marketing.
Stated simply, the task of the present invention is to provide an alginate-containing wound dressing which exhibits haemostatic properties, the dressing being characterized as being soft and highly pliant and being manufactured in an elegant and cost-effective manner which does not require the presence in the dressing of any chemicals other than the desired alginate for promoting wound healing.